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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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2.0 mm self tapping drill bit (AO-bayonet)
Inion Oy
0
Not in Commercial Distribution

  • M224INS90979 ()
INS-9097

  • Fluted surgical drill bit, reusable
Screwdriver shaft, hexalobular, cannulated
Inion Oy
0
In Commercial Distribution

  • M224INS90959 ()
INS-9095

  • Surgical screwdriver, reusable
Screwdriver shaft, crosshead
Inion Oy
0
In Commercial Distribution

  • M224INS90949 ()
INS-9094

  • Surgical screwdriver, reusable
4.5 mm cortex screw bone tap, cannulated
Inion Oy
0
In Commercial Distribution

  • M224INS90849 ()
INS-9084

  • Bone tap, reusable
2.8 mm bone tap with 42 mm stop (manual)
Inion Oy
0
Not in Commercial Distribution

  • M224INS90629 ()
INS-9062

  • Bone tap, reusable
2.5 mm bone tap with 32 mm stop
Inion Oy
0
Not in Commercial Distribution

  • M224INS90619 ()
INS-9061

  • Bone tap, reusable
2.0 mm bone tap with 22 mm stop
Inion Oy
0
In Commercial Distribution

  • M224INS90609 ()
INS-9060

  • Bone tap, reusable
1.5 mm bone tap with 16 mm stop
Inion Oy
0
In Commercial Distribution

  • M224INS90599 ()
INS-9059

  • Bone tap, reusable
Re-usable tack applicator
Inion Oy
0
In Commercial Distribution

  • M224INS90529 ()
INS-9052

  • Bone tack inserter, basic
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
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